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Background There is currently no formal prostate cancer screening programme in the UK. Early detection using age-based prostate-specific antigen (PSA) testing is unlikely to be cost-effective due to limited mortality benefit and harms associated with overdetection. However, the discovery of new prostate cancer specific biomarkers and more accurate diagnostic strategies (e.g. magnetic resonance imaging (MRI)) could improve the outcomes of screening. A systematic review was conducted to assess the evidence base on cost-effectiveness of such innovations and areas for further development. Methods To identify model-based economic evaluations of screening and diagnostic tests for prostate cancer, a systematic review of the literature using the NHS Economic Evaluation Database, Medline, EMBASE, HTA databases, NICE guidelines, and UK National Screening Committee guidance was carried out, between 2009 and 2019. Relevant data were extracted on study type, model inputs, modelling methods and cost-effectiveness conclusions and the results narratively synthesized. Results Sixteen studies were included in the review. Seven studies compared the cost-effectiveness of new urinary or blood biomarkers compared to each other or the PSA test and found the biomarkers e.g. the Prostate Health Index (PHI) and SelectMDx, to be the most cost-effective. Seven studies compared newer prostate biopsy methods, including MRI-guided, to TRUS guided biopsy and found MRI-guided methods to be most cost-effective. The newer detection methods showed a reduction in unnecessary biopsies and overtreatment. However, there was uncertainty around the most cost-effective pathway of follow-up strategies (MRI/biomarkers) in men who have a negative initial biopsy. Many studies did not model stage or grade of cancer, cancer progression or the entire testing, screening and treatment pathway. Very few studies fully accounted for uncertainty in their analysis. Conclusions This review brings together the cost-effectiveness literature for novel screening and testing methods used in the diagnosis of prostate cancer. Several limitations of the published models were identified. The models generally either compared new biomarkers or new imaging techniques which highlights the importance of future work in this area, as biomarkers and imaging are likely to be used in combination.

Background and ObjectiveMost guidelines in the UK, Europe and North America do not recommend organised population-wide screening for prostate cancer. Prostate-specific antigen-based screening can reduce prostate cancer-specific mortality, but there are concerns about overdiagnosis, overtreatment and economic value. The aim was therefore to assess the cost effectiveness of eight potential screening strategies in the UK.MethodsWe used a cost-utility analysis with an individual-based simulation model. The model was calibrated to data from the 10-year follow-up of the Cluster Randomised Trial of PSA Testing for Prostate Cancer (CAP). Treatment effects were modelled using data from the Prostate Testing for Cancer and Treatment (ProtecT) trial. The participants were a hypothetical population of 10 million men in the UK followed from age 30 years to death. The strategies were: no screening; five age-based screening strategies; adaptive screening, where men with an initial prostate-specific antigen level of < 1.5 ng/mL are screened every 6 years and those above this level are screened every 4 years; and two polygenic risk-stratified screening strategies. We assumed the use of pre-biopsy multi-parametric magnetic resonance imaging for men with prostate-specific antigen ≥ 3 ng/mL and combined transrectal ultrasound-guided and targeted biopsies. The main outcome measures were projected lifetime costs and quality-adjusted life-years from a National Health Service perspective.ResultsAll screening strategies increased costs compared with no screening, with the majority also increasing quality-adjusted life-years. At willingness-to-pay thresholds of £20,000 or £30,000 per quality-adjusted life-year gained, a once-off screening at age 50 years was optimal, although this was sensitive to the utility estimates used. Although the polygenic risk-stratified screening strategies were not on the cost-effectiveness frontier, there was evidence to suggest that they were less cost ineffective than the alternative age-based strategies.ConclusionsOf the prostate-specific antigen-based strategies compared, only a once-off screening at age 50 years was potentially cost effective at current UK willingness-to-pay thresholds. An additional follow-up of CAP to 15 years may reduce uncertainty about the cost effectiveness of the screening strategies.

OBJECTIVES: Smoking is a leading cause of death worldwide. Cessation aids include varenicline, bupropion, nicotine replacement therapy (NRT), and e-cigarettes at various doses (low, standard and high) and used alone or in combination with each other. Previous cost-effectiveness analyses have not fully accounted for adverse effects nor compared all cessation aids. The objective was to determine the relative cost-effectiveness of cessation aids in the United Kingdom.METHODS: An established Markov cohort model was adapted to incorporate health outcomes and costs due to depression and self-harm associated with cessation aids, alongside other health events. Relative efficacy in terms of abstinence and major adverse neuropsychiatric events was informed by a systematic review and network meta-analysis. Base case results are reported for UK-licensed interventions only. Two sensitivity analyses are reported, one including unlicensed interventions and another comparing all cessation aids but removing the impact of depression and self-harm. The sensitivity of conclusions to model inputs was assessed by calculating the expected value of partial perfect information.RESULTS: When limited to UK-licensed interventions, varenicline standard-dose and NRT standard-dose were most cost-effective. Including unlicensed interventions, e-cigarette low-dose appeared most cost-effective followed by varenicline standard-dose + bupropion standard-dose combined. When the impact of depression and self-harm was excluded, varenicline standard-dose + NRT standard-dose was most cost-effective, followed by varenicline low-dose + NRT standard-dose.CONCLUSION: Although found to be most cost-effective, combined therapy is currently unlicensed in the United Kingdom and the safety of e-cigarettes remains uncertain. The value-of-information analysis suggested researchers should continue to investigate the long-term effectiveness and safety outcomes of e-cigarettes in studies with active comparators.

Objective Challenges can exist when framing the decision question in a cost-effectiveness analysis, particularly when there is disagreement among experts on relevant comparators. Using prostate cancer screening and recent developments in risk stratification, early-detection biomarkers, and diagnostic technologies as a case study, we report a modified Delphi approach to handle decision-question uncertainty. Methods The study involved two rounds of anonymous online questionnaires to identify the prostate cancer screening strategies that international researchers, clinicians and decision makers felt important to consider in a cost-effectiveness model. Both purposive and snowball sampling were used to recruit experts. The questionnaire was based on a review of the literature and was piloted for language, comprehension and ease of use prior to dissemination. In Round 1, respondents indicated their preferred screening strategy (including no screening) through a series of multiple-choice questions. The responses informed a set of 13 consensus statements, which respondents ranked their agreement with on a 9-point Likert scale (Round 2). Consensus was considered reached if > 70% of participants indicated agreement and

Background Early pregnancy complications are common and account for the largest proportion of emergency work in gynaecology. Although early pregnancy assessment units operate in most UK acute hospitals, recent National Institute of Health and Care Excellence guidance emphasised the need for more research to identify configurations that provide the optimal balance between cost-effectiveness, clinical effectiveness and service- and patient-centred outcomes [National Institute for Health and Care Excellence (NICE). Ectopic Pregnancy and Miscarriage: Diagnosis and Initial Management. URL: http://guidance.nice.org.uk/CG154 (accessed 23 March 2016)]. Objectives The primary aim was to test the hypothesis that the rate of hospital admissions for early pregnancy complications is lower in early pregnancy assessment units with high consultant presence than in units with low consultant presence. The key secondary objectives were to assess the effect of increased consultant presence on other clinical outcomes, to explore patient satisfaction with the quality of care and to make evidence-based recommendations about the future configuration of UK early pregnancy assessment units. Design The Variations in the organisations of Early Pregnancy Assessment Units in the UK and their effects on clinical, Service and PAtient-centred outcomes (VESPA) study employed a multimethods approach and included a prospective cohort study of women attending early pregnancy assessment units to measure clinical outcomes, an economic evaluation, a patient satisfaction survey, qualitative interviews with service users, an early pregnancy assessment unit staff survey and a hospital emergency care audit. Setting The study was conducted in 44 early pregnancy assessment units across the UK. Participants Participants were pregnant women (aged ≥ 16 years) attending the early pregnancy assessment units or other hospital emergency services because of suspected early pregnancy complications. Staff members directly involved in providing early pregnancy care completed the staff survey. Main outcome measure Emergency hospital admissions as a proportion of women attending the participating early pregnancy assessment units. Methods Data sources – demographic and routine clinical data were collected from all women attending the early pregnancy assessment units. For women who provided consent to complete the questionnaires, clinical data and questionnaires were linked using the women’s study number. Data analysis and results reporting – the relationships between clinical outcomes and consultant presence, unit volume and weekend opening hours were investigated using appropriate regression models. Qualitative interviews with women, and patient and staff satisfaction, health economic and workforce analyses were also undertaken, accounting for consultant presence, unit volume and weekend opening hours. Results We collected clinical data from 6606 women. There was no evidence of an association between admission rate and consultant presence (p = 0.497). Health economic evaluation and workforce analysis data strands indicated that lower-volume units with no consultant presence were associated with lower costs than their alternatives. Limitations The relatively low level of direct consultant involvement could explain the lack of significant impact on quality of care. We were also unable to estimate the potential impact of factors such as scanning practices, level of supervision, quality of ultrasound equipment and clinical care pathway protocols. Conclusions We have shown that consultant presence in the early pregnancy assessment unit has no significant impact on key outcomes, such as the proportion of women admitted to hospital as an emergency, pregnancy of unknown location rates, ratio of new to follow-up visits, negative laparoscopy rate and patient satisfaction. All data strands indicate that low-volume units run by senior or specialist nurses and supported by sonographers and consultants may represent the optimal early pregnancy assessment unit configuration. Future work Our results show that further research is needed to assess the potential impact of enhanced clinical and ultrasound training on the performance of all disciplines working in early pregnancy assessment units. Trial registration Current Controlled Trials ISRCTN10728897. Funding This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 8, No. 46. See the NIHR Journals Library website for further project information.

Introduction Crisaborole topical ointment, 2%, is a nonsteroidal, topical anti-inflammatory phosphodiesterase-4 (PDE4) inhibitor that is approved for the treatment of mild-to-moderate atopic dermatitis (AD). The objective of the current analysis was to compare the efficacy of crisaborole 2% relative to pimecrolimus 1%, tacrolimus 0.03% and tacrolimus 0.1% in patients aged ≥ 2 years with mild-to-moderate AD by comparing improvement in Investigator’s Static Global Assessment scores ( (ISGA scores of 0/1 indicating “clear or almost clear”). ISGA was selected as the primary efficacy outcome given the US Food and Drug Administration’s recommendations on the use of ISGA for assessment of global severity in AD and to align with efficacy measurements in the crisaborole registration trials. Safety endpoints could not be analyzed due to differences in outcome definitions across studies. Methods Efficacy of crisaborole was evaluated using individual patient data (IPD) from two pivotal phase III randomized controlled trials (RCTs), and efficacy of comparators was evaluated using published RCTs included in a previous network meta-analysis. Vehicle controls were not comparable due to differences in ingredients and population imbalance and, therefore, an unanchored matching-adjusted indirect comparison (MAIC) was used, which reweighted IPD for crisaborole to estimate absolute response in comparator populations. Results The odds of achieving an improvement in ISGA score was higher with crisaborole 2% versus pimecrolimus 1% (odds ratio [OR] 2.03; 95% confidence interval [CI] 1.45–2.85; effective sample size = 627, reduced from 1021; p value

Polygenic risk is known to influence susceptibility to cancer. The use of data on polygenic risk, in conjunction with other predictors of future disease status, may offer significant potential for preventative care through risk-stratified screening programmes. An important element in the evaluation of screening programmes is their cost-effectiveness.We undertook a systematic review of papers evaluating the cost-effectiveness of screening interventions informed by polygenic risk scores compared to more conventional screening modalities. We included papers reporting cost-effectiveness outcomes in the English language published as articles or uploaded onto preprint servers with no restriction on date, type of cancer or form of polygenic risk modelled. We excluded papers evaluating screening interventions that did not report cost-effectiveness outcomes or which had a focus on monogenic risk. We evaluated studies using the Quality of Health Economic Studies checklist.Ten studies were included in the review, which investigated three cancers: prostate (n=5), colorectal (n=3) and breast (n=2). All study designs were cost-utility papers implemented as Markov models (n=6) or microsimulations (n=4). Nine of ten papers scored highly (score >75 on a 0-100) scale) when assessed using the Quality of Health Economic Studies checklist. Eight of ten studies concluded that polygenic risk informed cancer screening was likely to be more cost-effective than alternatives. However, the included studies lacked robust external data on the cost of polygenic risk stratification, did not account for how very large volumes of polygenic risk data on individuals would be collected and used, did not consider ancestry-related differences in polygenic risk, and did not fully account for downstream economic sequalae stemming from the use of polygenic risk data in these ways. These topics merit attention in future research on how polygenic risk data might contribute to cost-effective cancer screening.FundingThis work was supported by Cancer Research UK under grant number C18281/A29019. PD and RM are members of the MRC Integrative Epidemiology Unit at the University of Bristol which is supported by the Medical Research Council and the University of Bristol (MC_UU_12013/1, MC_UU_12013/9). PD, EK ad RMM received support from a Cancer Research UK (C18281/A29019) programme grant (the Integrative Cancer Epidemiology Programme). SW and JCT receive funding from the Oxford NIHR Biomedical Research Centre.RegistrationProspectively registered on PROSPERO database before searches commenced. Available at https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=243659

Background Cigarette smoking is one of the leading causes of early death. Varenicline [Champix (UK), Pfizer Europe MA EEIG, Brussels, Belgium; or Chantix (USA), Pfizer Inc., Mission, KS, USA], bupropion (Zyban; GlaxoSmithKline, Brentford, UK) and nicotine replacement therapy are licensed aids for quitting smoking in the UK. Although not licensed, e-cigarettes may also be used in English smoking cessation services. Concerns have been raised about the safety of these medicines and e-cigarettes. Objectives To determine the clinical effectiveness, safety and cost-effectiveness of smoking cessation medicines and e-cigarettes. Design Systematic reviews, network meta-analyses and cost-effectiveness analysis informed by the network meta-analysis results. Setting Primary care practices, hospitals, clinics, universities, workplaces, nursing or residential homes. Participants Smokers aged ≥ 18 years of all ethnicities using UK-licensed smoking cessation therapies and/or e-cigarettes. Interventions Varenicline, bupropion and nicotine replacement therapy as monotherapies and in combination treatments at standard, low or high dose, combination nicotine replacement therapy and e-cigarette monotherapies. Main outcome measures Effectiveness – continuous or sustained abstinence. Safety – serious adverse events, major adverse cardiovascular events and major adverse neuropsychiatric events. Data sources Ten databases, reference lists of relevant research articles and previous reviews. Searches were performed from inception until 16 March 2017 and updated on 19 February 2019. Review methods Three reviewers screened the search results. Data were extracted and risk of bias was assessed by one reviewer and checked by the other reviewers. Network meta-analyses were conducted for effectiveness and safety outcomes. Cost-effectiveness was evaluated using an amended version of the Benefits of Smoking Cessation on Outcomes model. Results Most monotherapies and combination treatments were more effective than placebo at achieving sustained abstinence. Varenicline standard plus nicotine replacement therapy standard (odds ratio 5.75, 95% credible interval 2.27 to 14.90) was ranked first for sustained abstinence, followed by e-cigarette low (odds ratio 3.22, 95% credible interval 0.97 to 12.60), although these estimates have high uncertainty. We found effect modification for counselling and dependence, with a higher proportion of smokers who received counselling achieving sustained abstinence than those who did not receive counselling, and higher odds of sustained abstinence among participants with higher average dependence scores. We found that bupropion standard increased odds of serious adverse events compared with placebo (odds ratio 1.27, 95% credible interval 1.04 to 1.58). There were no differences between interventions in terms of major adverse cardiovascular events. There was evidence of increased odds of major adverse neuropsychiatric events for smokers randomised to varenicline standard compared with those randomised to bupropion standard (odds ratio 1.43, 95% credible interval 1.02 to 2.09). There was a high level of uncertainty about the most cost-effective intervention, although all were cost-effective compared with nicotine replacement therapy low at the £20,000 per quality-adjusted life-year threshold. E-cigarette low appeared to be most cost-effective in the base case, followed by varenicline standard plus nicotine replacement therapy standard. When the impact of major adverse neuropsychiatric events was excluded, varenicline standard plus nicotine replacement therapy standard was most cost-effective, followed by varenicline low plus nicotine replacement therapy standard. When limited to licensed interventions in the UK, nicotine replacement therapy standard was most cost-effective, followed by varenicline standard. Limitations Comparisons between active interventions were informed almost exclusively by indirect evidence. Findings were imprecise because of the small numbers of adverse events identified. Conclusions Combined therapies of medicines are among the most clinically effective, safe and cost-effective treatment options for smokers. Although the combined therapy of nicotine replacement therapy and varenicline at standard doses was the most effective treatment, this is currently unlicensed for use in the UK. Future work Researchers should examine the use of these treatments alongside counselling and continue investigating the long-term effectiveness and safety of e-cigarettes for smoking cessation compared with active interventions such as nicotine replacement therapy. Study registration This study is registered as PROSPERO CRD42016041302. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 59. See the NIHR Journals Library website for further project information.

AimSickle cell disease (SCD) is a lifelong blood disorder affecting approximately 100,000 individuals in the United States (US). A number of new treatments have recently become available to improve SCD clinical outcomes, but it is unclear how treatment innovations that reduce disease severity could affect patients’ humanistic and economic outcomes.Methods and materialsTo answer this question, an online survey of US adult residents with a self-reported SCD diagnosis was conducted. Humanistic outcomes based on health-related quality of life (HRQoL)) were assessed during and outside of vaso-occlusive crises (VOCs). Economic outcomes were measured by annual household income and whether the respondent received disability insurance.ResultsAmong the 301 respondents completing the survey, average age was 34.4 years and 73.4% were female. Average HRQoL, measured using health utilities, were 0.311 (95% CI: 0.286, 0.337) during a VOC and 0.738 (0.720, 0.756) not during a VOC. The likelihood of claiming disability insurance was correlated with more frequent VOCs (0 VOCs: 12% vs. ≥4 VOCs: 47%, p = .002) and disease severity (Severity Class II: 16% vs. Severity Class III: 39%, p = .03). There was a weak relationship between VOC frequency and household income (0 VOCs: $47,488 vs. ≥4 VOCs: $34,569, p = .06) and no evidence of a relationship between disease severity class and income (Severity Class II: $42,443 vs. Severity Class III: $36,842, p = .29).ConclusionIn conclusion, disease severity, strongly predicted worse self-reported HRQoL, moderately predicted increased likelihood of collecting disability insurance, and weakly predicted lower household income levels.

Objective To determine whether the participation of consultant gynaecologists in delivering early pregnancy care results in a lower rate of acute hospital admissions. Design Prospective cohort study and emergency hospital care audit; data were collected as part of the national prospective mixed-methods VESPA study on the “Variations in the organization of EPAUs in the UK and their effects on clinical, Service and PAtient-centred outcomes”. Setting 44 Early Pregnancy Assessment Units (EPAUs) across the UK randomly selected in balanced numbers from eight pre-defined mutually exclusive strata. Participants 6606 pregnant women (≥16 years old) with suspected first trimester pregnancy complications attending the participating EPAUs or Emergency Departments (ED) from December 2016 to July 2017. Exposures Planned and actual senior clinician presence, unit size, and weekend opening. Main outcome measures Unplanned admissions to hospital following any visit for investigations or treatment for first trimester complications as a proportion of women attending EPAUs. Results 205/6397 (3.2%; 95% CI 2.8–3.7) women were admitted following their EPAU attendance. The admission rate among 44 units ranged from 0% to 13.7% (median 2.8). Neither planned senior clinician presence (p = 0.874) nor unit volume (p = 0.247) were associated with lower admission rates from EPAU, whilst EPAU opening over the weekend resulted in lower admission rates (p = 0.027). 1445/5464 (26.4%; 95%CI 25.3 to 27.6) women were admitted from ED. There was little evidence of an association with planned senior clinician time (p = 0.280) or unit volume (p = 0.647). Keeping an EPAU open over the weekend for an additional hour was associated with 2.4% (95% CI 0.1% to 4.7%) lower odds of an emergency admission from ED. Conclusions Involvement of senior clinicians in delivering early pregnancy care has no significant impact on emergency hospital admissions for early pregnancy complications. Weekend opening, however, may be an effective way of reducing emergency admissions from ED.

AIM: To determine how varenicline, bupropion, nicotine replacement therapy (NRT) and electronic cigarettes compare with respect to their clinical effectiveness and safety.METHOD: Systematic reviews and Bayesian network meta-analyses of randomized controlled trials, in any setting, of varenicline, bupropion, NRT and e-cigarettes (in high, standard and low doses, alone or in combination) in adult smokers and smokeless tobacco users with follow-up duration of 24 weeks or greater (effectiveness) or any duration (safety). Nine databases were searched until 19 February 2019. Primary outcomes were sustained tobacco abstinence and serious adverse events (SAEs). We estimated odds ratios (ORs) and treatment rankings and conducted meta-regression to explore covariates.RESULTS: We identified 363 trials for effectiveness and 355 for safety. Most monotherapies and combination therapies were more effective than placebo at helping participants to achieve sustained abstinence; the most effective of these, estimated with some imprecision, were varenicline standard [OR = 2.83, 95% credible interval (CrI) = 2.34-3.39] and varenicline standard + NRT standard (OR = 5.75, 95% CrI = 2.27-14.88). Estimates were higher in smokers receiving counselling than in those without and in studies with higher baseline nicotine dependence scores than in those with lower scores. Varenicline standard + NRT standard showed a high probability of being ranked best or second-best. For safety, only bupropion at standard dose increased the odds of experiencing SAEs compared with placebo (OR = 1.27, 95% CrI = 1.04-1.58), and we found no evidence of effect modification.CONCLUSIONS: Most tobacco cessation monotherapies and combination therapies are more effective than placebo at helping participants to achieve sustained abstinence, with varenicline appearing to be most effective based on current evidence. There does not appear to be strong evidence of associations between most tobacco cessation pharmacotherapies and adverse events; however, the data are limited and there is a need for improved reporting of safety data.

BackgroundWhen GPs suspect a brain tumour, a referral for specialist assessment and subsequent brain imaging is generally the first option. NICE have recommended that GPs have rapid direct access to brain imaging for adults with progressive sub-acute loss of central nervous function; however, no studies have evaluated the cost-effectiveness.MethodsWe developed a cost-effectiveness model based on data from one region of the UK with direct access computed tomography (DACT), routine data from GP records and the literature, to explore whether unrestricted DACT for patients with suspected brain tumour might be more cost-effective than criteria-based DACT or no DACT.ResultsAlthough criteria-based DACT allows some patients without brain tumour to avoid imaging, our model suggests this may increase costs of diagnosis due to non-specific risk criteria and high costs of diagnosing or ‘ruling out’ brain tumours by other pathways. For patients diagnosed with tumours, differences in outcomes between the three diagnostic strategies are small.ConclusionsUnrestricted DACT may reduce diagnostic costs; however, the evidence is not strong and further controlled studies are required. Criteria-based access to CT for GPs might reduce demand for DACT, but imperfect sensitivity and specificity of current risk stratification mean that it will not necessarily be cost-effective.

Background Clinical trials report severe hypoglycaemic events as the number of patients with at least one event out of the total randomised or number of events for a given total exposure. Different network meta-analysis models have been used to analyse these different data types. Objective This aim of this article was to establish the impact of using the different models on effectiveness, costs and health utility estimates. Methods We analysed a dataset used in a recent network meta-analysis of severe hypoglycaemic events conducted to inform National Institute for Health and Care Excellence recommendations regarding basal insulin choice for patients with type 1 diabetes mellitus. We fitted a model with a binomial likelihood reporting odds ratios (using a logit link) or hazard ratios (complementary log-log link), a model with a Poisson likelihood reporting hazard ratios and a shared-parameter model combining different types of data. We compared the results in terms of relative effects and resulting cost and disutility estimates. Results Relative treatment effects are similar regardless of which model or scale is used. Differences were seen in the probability of having an event on the baseline treatment with the logit model giving a baseline probability of 0.07, the complementary log-log 0.17 and the Poisson 0.29. These translate into differences of up to £110 in the yearly cost of a hypoglycaemic event and 0.004 in disutility. Conclusion While choice of network meta-analysis model does not have a meaningful impact on relative effects for this outcome, care should be taken to ensure that the baseline probabilities used in an economic model are accurate to avoid misrepresenting costs and effects. Electronic supplementary material The online version of this article (10.1007/s40273-018-0612-y) contains supplementary material, which is available to authorized users.

ObjectivesIn young and middle-aged adults, there are three current options for aortic valve replacement (AVR), namely mechanical AVR (mechAVR), tissue AVR (biological AVR) and the Ross operation, with no clear guidance on the best option. We aim to compare the clinical effectiveness and cost-effectiveness of the Ross procedure with conventional AVR in young and middle-aged adults.MethodsThis is a systematic literature review and meta-analysis of AVR options. Markov multistate model was adopted to compare cost-effectiveness. Lifetime costs, quality-adjusted life years (QALYs), net monetary benefit (NMB), population expected value of perfect information (EVPI) and expected value of partial perfect information were estimated.ResultsWe identified 48 cohorts with a total number of 12 975 patients (mean age 44.5 years, mean follow-up 7.1 years). Mortality, bleeding and thromboembolic events over the follow-up period were lowest after the Ross operation, compared with mechAVR and biological AVR (pAt a willingness-to-pay threshold of £20 000 per QALY, the Ross procedure is more cost-effective compared with conventional AVR, with a lifetime incremental NMB of £60 952 (£30 236 to £79 464). Incremental costs were £12 323 (£6108 to £15 972) and incremental QALYs 3.66 (1.81 to 4.76). The population EVPI indicates that a trial costing up to £2.03 million could be cost-effective.ConclusionsIn young and middle-aged adults with aortic valve disease, the Ross procedure may confer greater quality of life and be more cost-effective than conventional AVR. A high-quality randomised trial could be warranted and cost-effective.

Background Brain tumour patients see their primary care doctor on average three or more times before diagnosis, so there may be an opportunity to identify ‘at risk’ patients earlier. Suspecting a brain tumour diagnosis is difficult because brain tumour-related symptoms are typically non-specific. Methods We explored the predictive value of referral guidelines (Kernick and NICE 2005) for brain imaging where a tumour is suspected, in a population-based patient group referred for direct access CT of the head. A consensus panel reviewed whether non-tumour findings were clinically important or whether further investigation was necessary. Results Over a 5-year period, 3257 head scans were performed; 318 scans were excluded according to pre-specified criteria. 53 patients (1.8%) were reported to have intracranial tumours, of which 42 were significant (diagnostic yield of 1.43%). There were no false negative CT scans for tumour. With symptom-based referral guidelines primary care doctors can identify patients with a 3% positive predictive value (PPV). 559 patients had non-tumour findings, 31% of which were deemed clinically significant. In 34% of these 559 patients, referral for further imaging and/or specialist assessment from primary care was still thought warranted. Conclusion Existing referral guidelines are insufficient to stratify patients adequately based on their symptoms, according to the likelihood that a tumour will be found on brain imaging. Identification of non-tumour findings may be significant for patients and earlier specialist input into interpretation of these images may be beneficial. Improving guidelines to better identify patients at risk of a brain tumour should be a priority, to improve speed of diagnosis, and reduce unnecessary imaging and costs. Future guidelines may incorporate groups of symptoms, clinical signs and tests to improve the predictive value.

Background: Long-acting bronchodilators such as long-acting β-agonist (LABA), long-acting muscarinic antagonist (LAMA), and LABA/inhaled corticosteroid (ICS) combinations have been used in people with moderate to severe chronic obstructive pulmonary disease (COPD) to control symptoms such as dyspnoea and cough, and prevent exacerbations. A number of LABA/LAMA combinations are now available for clinical use in COPD. However, it is not clear which group of above mentioned inhalers is most effective or if any specific formulation works better than the others within the same group or class. Objectives: To compare the efficacy and safety of available formulations from four different groups of inhalers (i.e. LABA/LAMA combination, LABA/ICS combination, LAMA and LABA) in people with moderate to severe COPD. The review will update previous systematic reviews on dual combination inhalers and long-acting bronchodilators to answer the questions described above using the strength of a network meta-analysis (NMA). Search methods: We identified studies from the Cochrane Airways Specialised Register, which contains several databases. We also conducted a search of ClinicalTrials.gov and manufacturers' websites. The most recent searches were conducted on 6 April 2018. Selection criteria: We included randomised controlled trials (RCTs) that recruited people aged 35 years or older with a diagnosis of COPD and a baseline forced expiratory volume in one second (FEV1) of less than 80% of predicted. We included studies of at least 12 weeks' duration including at least two active comparators from one of the four inhaler groups. Data collection and analysis: We conducted NMAs using a Bayesian Markov chain Monte Carlo method. We considered a study as high risk if recruited participants had at least one COPD exacerbation within the 12 months before study entry and as low risk otherwise. Primary outcomes were COPD exacerbations (moderate to severe and severe), and secondary outcomes included symptom and quality-of-life scores, safety outcomes, and lung function. We collected data only for active comparators and did not consider placebo was not considered. We assumed a class/group effect when a fixed-class model fitted well. Otherwise we used a random-class model to assess intraclass/group differences. We supplemented the NMAs with pairwise meta-analyses. Main results: We included a total of 101,311 participants from 99 studies (26 studies with 32,265 participants in the high-risk population and 73 studies with 69,046 participants in the low-risk population) in our systematic review. The median duration of studies was 52 weeks in the high-risk population and 26 weeks in the low-risk population (range 12 to 156 for both populations). We considered the quality of included studies generally to be good. The NMAs suggested that the LABA/LAMA combination was the highest ranked treatment group to reduce COPD exacerbations followed by LAMA in the both populations. There is evidence that the LABA/LAMA combination decreases moderate to severe exacerbations compared to LABA/ICS combination, LAMA, and LABA in the high-risk population (network hazard ratios (HRs) 0.86 (95% credible interval (CrI) 0.76 to 0.99), 0.87 (95% CrI 0.78 to 0.99), and 0.70 (95% CrI 0.61 to 0.8) respectively), and that LAMA decreases moderate to severe exacerbations compared to LABA in the high- and low-risk populations (network HR 0.80 (95% CrI 0.71 to 0.88) and 0.87 (95% CrI 0.78 to 0.97), respectively). There is evidence that the LABA/LAMA combination reduces severe exacerbations compared to LABA/ICS combination and LABA in the high-risk population (network HR 0.78 (95% CrI 0.64 to 0.93) and 0.64 (95% CrI 0.51 to 0.81), respectively). There was a general trend towards a greater improvement in symptom and quality-of-life scores with the combination therapies compared to monotherapies, and the combination therapies were generally ranked higher than monotherapies. The LABA/ICS combination was the lowest ranked in pneumonia serious adverse events (SAEs) in both populations. There is evidence that the LABA/ICS combination increases the odds of pneumonia compared to LAMA/LABA combination, LAMA and LABA (network ORs: 1.69 (95% CrI 1.20 to 2.44), 1.78 (95% CrI 1.33 to 2.39), and 1.50 (95% CrI 1.17 to 1.92) in the high-risk population and network or pairwise OR: 2.33 (95% CI 1.03 to 5.26), 2.02 (95% CrI 1.16 to 3.72), and 1.93 (95% CrI 1.29 to 3.22) in the low-risk population respectively). There were significant overlaps in the rank statistics in the other safety outcomes including mortality, total, COPD, and cardiac SAEs, and dropouts due to adverse events. None of the differences in lung function met a minimal clinically important difference criterion except for LABA/LAMA combination versus LABA in the high-risk population (network mean difference 0.13 L (95% CrI 0.10 to 0.15). The results of pairwise meta-analyses generally agreed with those of the NMAs. There is no evidence to suggest intraclass/group differences except for lung function at 12 months in the high-risk population. Authors' conclusions: The LABA/LAMA combination was the highest ranked treatment group to reduce COPD exacerbations although there was some uncertainty in the results. LAMA containing inhalers may have an advantage over those without a LAMA for preventing COPD exacerbations based on the rank statistics. Combination therapies appear more effective than monotherapies for improving symptom and quality-of-life scores. ICS-containing inhalers are associated with an increased risk of pneumonia. Our most comprehensive review including intraclass/group comparisons, free combination therapies, 99 studies, and 20 outcomes for each high- and low-risk population summarises the current literature and could help with updating existing COPD guidelines.

BackgroundBulimia nervosa (BN) is a severe eating disorder that can be managed using a variety of treatments including pharmacological, psychological, and combination treatments. We aimed to compare their effectiveness and to identify the most effective for the treatment of BN in adults.MethodsA search was conducted in Embase, Medline, PsycINFO, and Central from their inception to July 2016. Studies were included if they reported on treatments for adults who fulfilled diagnostic criteria for BN. Only randomised controlled trials (RCTs) that examined available psychological, pharmacological, or combination therapies licensed in the UK were included. We conducted a network meta-analysis (NMA) of RCTs. The outcome analysed was full remission at the end of treatment.ResultsWe identified 21 eligible trials with 1828 participants involving 12 treatments, including wait list. The results of the NMA suggested that individual cognitive behavioural therapy (CBT) (specific to eating disorders) was most effective in achieving remission at the end of treatment compared with wait list (OR 3.89, 95% CrI 1.19–14.02), followed by guided cognitive behavioural self-help (OR 3.81, 95% CrI 1.51–10.90). Inconsistency checks did not identify any significant inconsistency between the direct and indirect evidence.ConclusionsThe analysis suggested that the treatments that are most likely to achieve full remission are individual CBT (specific to eating disorders) and guided cognitive behavioural self-help, although no firm conclusions could be drawn due to the limited evidence base. There is a need for further research on the maintenance of treatment effects and the mediators of treatment outcome.

Introduction: Sickle cell disease (SCD) affects approximately 100,000 people in the United States (US) today. SCD can lead to painful vaso-occlusive crises (VOCs), damage to major organs, increased vulnerability to severe infections, and as such, affects a patient's health-related quality of life (HRQoL). The objective of this study was to quantify how disease severity and the presence of VOCs affects patient quality of life, as measured by the economic metric of patient utilities. While previous studies (Anie et al. 2012) have measured utilities among patients with SCD in the United Kingdom (UK), this is the first US study to evaluate utilities in patients with SCD during and outside the experience of a VOC. Methods: This study was a non-interventional, cross-sectional, online survey of patients with SCD. Individuals were recruited through SCD patient advocacy groups and a market research group. In this analysis, the outcome of interest was health utility values derived from the EuroQoL Five Dimension 5 level (EQ-5D) scale. Utility is a continuous measure of health status, where a utility of 1 represents perfect health, and a utility of 0 represents death. The EQ-5D survey responses were converted to EQ-5D health utilities using the United States EuroQoL value set, and EQ-5D health utility values (mean and 95% confidence intervals [CI]) were estimated. Respondents completed the EQ-5D question twice: once in reference to their health status when they were not experiencing a VOC and once in reference to their health status when experiencing a VOC. We estimated EQ-5D for both these measures. For EQ-5D not during VOC we estimated EQ-5D stratified by three classes of disease severity. These classes were informed by clinical expert severity. Respondents were classified as Severity Class I if they had no history of VOC requiring treatment by health care providers in the past year; Class II if they had ≥1 emergency department (ED) visit or hospital admission in the past year without organ damage; and Class III if they had long term organ damage (such as stroke or renal disease). Results: 326 individuals were screened and 299 individuals were included in the final analytic sample. Among these individuals, the average age was 34.3 years (range 18 - 72); 219 (73.2%) were female and 1 (0.3%) was non-binary. Based on self-report of VOC, as well as presence of complications and organ damage of individuals, 79.6% (238/299) were Severity Class III, 12.0% (36/299) were Class II, and 8.4% (25/299) Class I. The estimated health utility value derived from EQ-5D during VOC was 0.311 (95% CI: 0.286, 0.337). The estimated health utility values not during a VOC derived from EQ-5D was 0.733 (0.713, 0.753) for Severity Class III and 0.775 (0.725, 0.826) for Severity Class II. This result suggests >5% worse health status utility in Class III than Class II disease severity, although a Wald t-test for difference in means did not suggest evidence of a statistically significant difference in utility (p-value 0.13). Conclusion: The presence of VOC had a more severe impact on HRQoL for patients with SCD than previously estimated. When not experiencing a crisis, patients with Severity Class III, indicated by presence of organ damage, had >5% worse HRQoL than those with Severity Class II. Disclosures Thom: Novartis Pharma AG: Consultancy; Pfizer: Consultancy; Hoffman-La Roche: Consultancy; Bayer AG: Consultancy. Shafrin:Precision Health Economics, part of Precision Medicine Group: Employment, Equity Ownership. Keeney:Novartis Pharma AG: Consultancy; Pfizer: Consultancy. Zhao:Precision Health Economics, part of Precision Medicine Group: Employment. Joseph:Cigna: Equity Ownership; Pfizer: Equity Ownership; Amgen: Equity Ownership; Novartis: Employment, Equity Ownership. Bhor:Novartis: Employment, Equity Ownership. Rizio:Optum: Employment. Bronté-Hall:bluebird bio: Research Funding. Shah:GBT: Research Funding; Alexion: Speakers Bureau; Novartis: Consultancy, Research Funding, Speakers Bureau.

Objectives To assess the effectiveness and safety of prostaglandins used for labour induction. Design Systematic review with Bayesian network meta-analysis Data sources The Cochrane Pregnancy and Childbirth Group’s Database of Trials (which incorporates the results of a broad generic search for all pregnancy and postpartum trials). Sources included are CENTRAL, Medline, Embase, NHS Economic Evaluation Database, CINAHL, relevant journals, conference proceedings, and registries of ongoing trials. Eligibility criteria for selecting studies Randomised clinical trials of prostaglandin or prostaglandin analogues used for third trimester cervical ripening or labour induction versus placebo or no treatment, alternative prostaglandin dose or administration, or a different type of prostaglandin. We included studies recruiting women with a viable fetus, but had no other restrictions relating to indication for labour induction or language of publication. Outcomes assessed were serious neonatal morbidity (trialist defined) or perinatal death; serious maternal morbidity (trialist defined) or death; vaginal delivery not achieved within 24 hours, caesarean section, and uterine hyperstimulation with fetal heart rate changes. Results 280 randomised clinical trials were included (48 068 women) in the review. Maternal and neonatal mortality and serious morbidity were rarely reported and are summarized narratively. Unresolved inconsistency was observed for the hyperstimulation outcome. Relative to placebo, the odds of failing to achieve a vaginal delivery were lowest for vaginal misoprostol (≥50 µg) (odds ratio 0.06 (95% credible interval 0.02 to 0.12)), with a 39% absolute probability of event (95% credible interval 1% to 94%). Compared with placebo, odds of caesarean section were lowest for titrated oral misoprostol solution ( Conclusions Low dose( Systematic review registration PROSPERO 2013:CRD42013005116

BackgroundMore than 150,000 pregnant women in England and Wales have their labour induced each year. Multiple pharmacological, mechanical and complementary methods are available to induce labour.ObjectiveTo assess the relative effectiveness, safety and cost-effectiveness of labour induction methods and, data permitting, effects in different clinical subgroups.MethodsWe carried out a systematic review using Cochrane methods. The Cochrane Pregnancy and Childbirth Group’s Trials Register was searched (March 2014). This contains over 22,000 reports of controlled trials (published from 1923 onwards) retrieved from weekly searches of OVID MEDLINE (1966 to current); Cochrane Central Register of Controlled Trials (The Cochrane Library); EMBASE (1982 to current); Cumulative Index to Nursing and Allied Health Literature (1984 to current); ClinicalTrials.gov; the World Health Organization International Clinical Trials Registry Portal; and hand-searching of relevant conference proceedings and journals. We included randomised controlled trials examining interventions to induce labour compared with placebo, no treatment or other interventions in women eligible for third-trimester induction. We included outcomes relating to efficacy, safety and acceptability to women. In addition, for the economic analysis we searched the Database of Abstracts of Reviews of Effects, and Economic Evaluations Databases, NHS Economic Evaluation Database and the Health Technology Assessment database. We carried out a network meta-analysis (NMA) using all of the available evidence, both direct and indirect, to produce estimates of the relative effects of each treatment compared with others in a network. We developed a de novo decision tree model to estimate the cost-effectiveness of various methods. The costs included were the intervention and other hospital costs incurred (price year 2012–13). We reviewed the literature to identify preference-based utilities for the health-related outcomes in the model. We calculated incremental cost-effectiveness ratios, expected costs, utilities and net benefit. We represent uncertainty in the optimal intervention using cost-effectiveness acceptability curves.ResultsWe identified 1190 studies; 611 were eligible for inclusion. The interventions most likely to achieve vaginal delivery (VD) within 24 hours were intravenous oxytocin with amniotomy [posterior rank 2; 95% credible intervals (CrIs) 1 to 9] and higher-dose (≥ 50 µg) vaginal misoprostol (rank 3; 95% CrI 1 to 6). Compared with placebo, several treatments reduced the odds of caesarean section, but we observed considerable uncertainty in treatment rankings. For uterine hyperstimulation, double-balloon catheter had the highest probability of being among the best three treatments, whereas vaginal misoprostol (≥ 50 µg) was most likely to increase the odds of excessive uterine activity. For other safety outcomes there were insufficient data or there was too much uncertainty to identify which treatments performed ‘best’. Few studies collected information on women’s views. Owing to incomplete reporting of the VD within 24 hours outcome, the cost-effectiveness analysis could compare only 20 interventions. The analysis suggested that most interventions have similar utility and differ mainly in cost. With a caveat of considerable uncertainty, titrated (low-dose) misoprostol solution and buccal/sublingual misoprostol had the highest likelihood of being cost-effective.LimitationsThere was considerable uncertainty in findings and there were insufficient data for some planned subgroup analyses.ConclusionsOverall, misoprostol and oxytocin with amniotomy (for women with favourable cervix) is more successful than other agents in achieving VD within 24 hours. The ranking according to safety of different methods was less clear. The cost-effectiveness analysis suggested that titrated (low-dose) oral misoprostol solution resulted in the highest utility, whereas buccal/sublingual misoprostol had the lowest cost. There was a high degree of uncertainty as to the most cost-effective intervention.Future workFuture trials should be powered to detect a method that is more cost-effective than misoprostol solution and report outcomes included in this NMA.Study registrationThis study is registered as PROSPERO CRD42013005116.FundingThe National Institute for Health Research Health Technology Assessment programme.

Objectives To compare the clinical effectiveness and cost‐effectiveness of labour induction methods. Methods We conducted a systematic review of randomised trials comparing interventions for third‐trimester labour induction (search date: March 2014). Network meta‐analysis was possible for six of nine prespecified key outcomes: vaginal delivery within 24 hours (VD24), caesarean section, uterine hyperstimulation, neonatal intensive care unit (NICU) admissions, instrumental delivery and infant Apgar scores. We developed a decision‐tree model from a UK NHS perspective and calculated incremental cost‐effectiveness ratios, expected costs, utilities and net benefit, and cost‐effectiveness acceptability curves. Main results In all, 611 studies comparing 31 active interventions were included. Intravenous oxytocin with amniotomy and vaginal misoprostol (≥50 μg) were most likely to achieve VD24. Titrated low‐dose oral misoprostol achieved the lowest odds of caesarean section, but there was considerable uncertainty in ranking estimates. Vaginal (≥50 μg) and buccal/sublingual misoprostol were most likely to increase uterine hyperstimulation with high uncertainty in ranking estimates. Compared with placebo, extra‐amniotic prostaglandin E2 reduced NICU admissions. There were insufficient data to conduct analyses for maternal and neonatal mortality and serious morbidity or maternal satisfaction. Conclusions were robust after exclusion of studies at high risk of bias. Due to poor reporting of VD24, the cost‐effectiveness analysis compared a subset of 20 interventions. There was considerable uncertainty in estimates, but buccal/sublingual and titrated (low‐dose) misoprostol showed the highest probability of being most cost‐effective. Conclusions Future trials should be designed and powered to detect a method that is more cost‐effective than low‐dose titrated oral misoprostol. Tweetable abstract New study ranks methods to induce labour in pregnant women on effectiveness and cost., Tweetable abstract New study ranks methods to induce labour in pregnant women on effectiveness and cost.

Patients with brain tumors often have subtle cognitive change, which may go unnoticed by patient and family doctor. This may result in delays in diagnosis. We studied the relationship between first and subsequent symptoms and semantic verbal fluency test (SVFT), a quick cognitive screening test. (Normal median SVFT for 60–79 age range who have 12 years of education = 17 animals; 10th percentile is 12 animals). Patients with new intrinsic brain tumors had structured patient interviews to determine first and subsequent symptoms. Patients were specifically asked about cognition. A cognitive screening test (SVFT – how many animals can you think of in a minute) was performed in patients as part of the Addenbrookes Cognitive Exam on admission. Symptoms were categorized into focal, non-focal, episodic attack or headache. 127 patients with cerebral brain tumors were assessed– glioma (n=94 HGG=79;LGG=15); metastasis (n= 28); primary CNS lymphoma (n=5). Mean age, 56.2, (SD 13.1): 55% male. 16 patients presented with a solitary symptom (episodic (9); focal (4); headache (3); non-focal (0)). As symptoms accumulated time to diagnosis increased “1 symptom” (med 23 days); “2 symptoms” (med 42 days) “>=3 symptoms” (med 44 days). Mean SVFT was lowest in HGG (mean 10.9) vs LGG (mean 15.7). Patient awareness of cognitive problems did not correlate with SVFT score (aware (n=50) mean 11.9 v unaware (n=77) mean 11.7)) Presentation with an isolated cognitive complaint is uncommon in cerebral brain tumors. Diagnosis becomes apparent when combined with headache or focal symptoms. Diagnosis becomes easier when multiple symptoms accumulate, but there are increasing delays. Many patients with headache also have asymptomatic cognitive problems on SVFT. Where there is a suspicion of cerebral problem e.g. headache suspicious of cancer, it is insufficient just to ask patients whether they have cognitive problems. SVFT may be a helpful red flag.

Background Labour inductions have increased steadily over the past two decades, with overall rates in many countries now exceeding 20% of all births. We have conducted a systematic review, network meta-analysis and cost-effectiveness analysis to determine which treatments for induction perform best on pre-specified safety and efficacy outcomes. This poster reports analysis of the outcomes reported in trials.

ObjectivesPublished clinical trials report severe hypoglycaemic events in different ways. Some report number of patients who suffered at least one event out of total number randomised and others report number of events for a given total exposure. The different data types can be modelled in different ways; therefore, three models have been used in published Bayesian Network Meta Analyses (NMAs) of hypoglycaemic events; models with a binomial likelihood reporting odds ratios (using a logit link) or hazard ratios (using the complementary log log link) and models with a Poisson likelihood reporting hazard ratios. The objective of this paper is to establish the impact of using different models on effectiveness estimates and the outputs from cost-effectiveness models.MethodsWe analysed a dataset used in a recent NMA conducted to inform NICE guideline recommendations regarding insulin choice for patients with type 1 diabetes using the three previously used models, plus a shared parameter model combining different types of data.ResultsThe relative treatment effects are similar regardless of which model or scale is used. Differences were seen when the probability of having an event on the baseline treatment was calculated using the different models with the logit model giving a baseline probability of 0.07, the clog-log 0.17 and the Poisson 0.29. These translate into differences of up to £110 in the cost of a hypoglycaemic event and 0.004 in associated disutility when calculating the absolute probabilities of an event to use in an economic model.ConclusionsWhile choice of outcome measure may not have a significant impact on relative effects for this outcome, care should be taken to ensure that the baseline probabilities used in an economic model are realistic and accurate to avoid over or underestimating costs and effects.

OBJECTIVES: To assess the effectiveness and safety of prostaglandins used for labour induction.DESIGN: Systematic review with Bayesian network meta-analysisDATA SOURCES: The Cochrane Pregnancy and Childbirth Group's Database of Trials (which incorporates the results of a broad generic search for all pregnancy and postpartum trials). Sources included are CENTRAL, Medline, Embase, NHS Economic Evaluation Database, CINAHL, relevant journals, conference proceedings, and registries of ongoing trials.ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Randomised clinical trials of prostaglandin or prostaglandin analogues used for third trimester cervical ripening or labour induction versus placebo or no treatment, alternative prostaglandin dose or administration, or a different type of prostaglandin. We included studies recruiting women with a viable fetus, but had no other restrictions relating to indication for labour induction or language of publication. Outcomes assessed were serious neonatal morbidity (trialist defined) or perinatal death; serious maternal morbidity (trialist defined) or death; vaginal delivery not achieved within 24 hours, caesarean section, and uterine hyperstimulation with fetal heart rate changes.RESULTS: 280 randomised clinical trials were included (48 068 women) in the review. Maternal and neonatal mortality and serious morbidity were rarely reported and are summarized narratively. Unresolved inconsistency was observed for the hyperstimulation outcome. Relative to placebo, the odds of failing to achieve a vaginal delivery were lowest for vaginal misoprostol (≥50 µg) (odds ratio 0.06 (95% credible interval 0.02 to 0.12)), with a 39% absolute probability of event (95% credible interval 1% to 94%). Compared with placebo, odds of caesarean section were lowest for titrated oral misoprostol solution (CONCLUSIONS: Low dose(SYSTEMATIC REVIEW REGISTRATION: PROSPERO 2013:CRD42013005116.

As more complex meta-analytical techniques such as network and multivariate meta-analyses become increasingly common, further pressures are placed on reviewers to extract data in a systematic and consistent manner. Failing to do this appropriately wastes time, resources and jeopardises accuracy. This guide (data extraction for complex meta-analysis (DECiMAL)) suggests a number of points to consider when collecting data, primarily aimed at systematic reviewers preparing data for meta-analysis. Network meta-analysis (NMA), multiple outcomes analysis and analysis combining different types of data are considered in a manner that can be useful across a range of data collection programmes. The guide has been shown to be both easy to learn and useful in a small pilot study. Electronic supplementary material The online version of this article (doi:10.1186/s13643-016-0368-4) contains supplementary material, which is available to authorized users.